Medical Writer

Company: QurAlis
Location: Cambridge
Posted on: July 31, 2022

Job Description:

ABOUT THE COMPANYThe QurAlis mission is an unrelenting commitment to enhance patients' lives through development and commercialization of next-generation precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. QurAlis is applying precision oncology-like approaches in neuroscience---, understanding and identifying sub-groups ---of patients for the right therapy---. -QurAlis is building a fully-integrated, next-generation, high performance precision medicine company.--- Together with a world-class network of thought leaders,---drug developers, and patient advocates, our growing team is at the leading edge of---neurodegenerative research and development.---We are advancing both antisense and small molecule programs addressing sub-forms---of ALS and frontotemporal dementia (FTD) that together account for most patients. Our two main programs are aimed to start clinical trials in H2 2022. We have developed two proprietary platforms: the QR43TM TDP43 platform and the FlexASOTM antisense---oligonucleotide (ASO) splice modulator platform---. - -QurAlis is honored to have won the Fierce15 and the New England Venture Capital---Association's NEVY award for Best Emerging Life Science Company in New England's startup---ecosystem. We are pioneers in neurodegenerative disease biology, stem cell and ASO technology, biomarkers, and small molecule design. We are honest and---empathetic to our patient community, science, colleagues, and ourselves sharing a common---passion to urgently discover new medicines for ALS and FTD. We represent a diversity of---backgrounds and value collaboration. We believe that success in treating neurodegenerative---diseases will be achieved by being precise - targeting the right patients, identifying the right---disease mechanism, and carefully developing disease-modifying, clinically meaningful therapies---to improve the lives of patients. -Summary of PositionQurAlis is seeking a highly motivated Medical Writer to author clinical and regulatory documents and to server as a cross-functional team member for clinical study level activities.Primary Job Responsibilities

• Authors routine clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, and investigator's brochures, and sections of regulatory submissions) in partnership with cross-functional team with oversight experience across multiple jurisdictions -
  • Supports clinical study execution through expert review of study-level documents authored by other functions (e.g., study deviations, analysis plans, data outputs)
    • Collaborates with cross-functional team to review study results
      • Contributes scientific knowledge and analytical skills to the production of documents
        • Participates in developing key messages for routine documents and conduct literature searches
          • Develops timelines for documents and communicates with team members to maintain awareness of expectations, milestones, and deliverables
            • Reviews clinical trial registry postings for assigned studies
              • Works effectively with an electronic document management system and related tools to develop clinical documentsMinimum Qualifications Required
                • Bachelors degree in relevant discipline
                • Ph.D. (or equivalent degree)
                • 2+ years of experience or the equivalent combination of education and experience
                • Meticulous nature with high attention to detail
                • Able to work independently and work well in a team environment in a fast-paced environment
                • Strong organizational skills
                • Excellent written and oral communication with key stakeholders and work collaborativelyAdditional Qualifications Desired
                  • Background in neuroscience beneficial either through work or educational experience
                  • Experience with regulatory documents, protocols, Investigator Brochures
                    

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